Obstructive sleep apnea is a significant chronic disease which pervasively effects the general population. The projected rate of sleep apnea in the general population, comparable to the rates of hypertension and obesity, is higher than the rates of breast cancer and diabetes combined. The prevalence of obstructive sleep apnea, however, is obscured due to poor screening and poor public awareness. Among middle-aged individuals, many of the women and men who have moderate to severe sleep apnea have not been screened, identified, or diagnosed.
Individuals with untreated sleep disorders are at higher risks for associated chronic conditions which lead to significant increased health care costs, disability, and even death. Included among these heightened risks are hypertension, stroke, sudden death at night, any cardiovascular death, auto accidents, and work place accidents. These undiagnosed individuals utilize significantly more healthcare costs than their counterparts of the same-age without a sleep disorder. Among adults from 18 to 34 years old, approximately half report that daytime sleepiness interferes with their daily work resulting in significant productivity losses. Employees with excessive daytime sleepiness are also more likely to be involved in an occupational accident. Fatal and non-fatal occupational injuries detract from revenue in the forms lost wages and productivity, administrative expenses, healthcare, and other costs.
Today sparingly few individuals with obstructive sleep apnea are identified and treated. When the few are treated, it is uncommon to collect or utilize information obtained from home sleep therapy machines to determine therapy effectiveness. Even when the electronic data is accessed for a report, the individual's rights of privacy/security of their electronic data are not protected as required by recent Federal regulations, such as the HIPAA HITECH Act. The lack of compliance in this regard results in poor data preservation, often leading to the loss of the electronic data both to the patient and to other future point of care providers.
There are multiple devices, products, and services in the area of sleep disorders, but current technology is inefficient, costly, and ineffective.
The conventional steps to diagnose a consumer with a sleep disorder start with the Primary Care Physician (PCP) or specialist identifying the need for testing to diagnose a sleep disorder. This is affected by physician awareness, i.e., if the physician thinks to asks the screening questions, and if they think treating a sleep disorder is important, then they will pursue a diagnosis. The current identification of consumers with possible sleep disorders has produced the under-diagnosis rate of 93% for females and 82% for males.
Next, the physician may request a sleep study, and the first polysomnogram (PSG) is usually performed in a sleep laboratory. Because of poor access and availability, the time for scheduling is the first delay among a series of weeks to months of delays to diagnose and treat the sleep disorder. The patient arrives to an unfamiliar facility and is wired for data collection. While the consumer is sleeping a technician will assist in collecting the multiple channels of complex information. The technician's training can vary from: on-the-job training with no medical background requirement; no medical background and an 80 hour American Academy of Sleep Medicine (AASM) A-STEP course; healthcare professionals cross-trained for sleep disorders with no course requirements; and meeting the required work period and passing the registry exam to earn the credentials of Registered Polysomnographic Technologist (RPSGT). The unqualified or under qualified technician can produce “Therapy Errors” as described below.
At some facilities, technicians or technologists simply record signals and monitor the patient during the PSG. At other facilities, the technicians/technologists are responsible for staging the sleep changes and scoring any respiratory, cardiac, or limb events which occur during sleep. Due to the differences in the levels of knowledge and performance, the results and accuracy of the studies may vary greatly. This leads to poor inter-scorer reliability of the technicians and unreliable quality of the studies. The medical director is responsible for interpreting the study. Currently there is no inter-rater reliability quality monitoring for physicians providing the interpretations.
The referring physician will request an office visit to review the results—a second delay in diagnosis and treatment. Once diagnosed with sleep-disordered breathing the consumer returns to the sleep lab for a second study to determine the level of Continuous Positive Airway Pressure (CPAP), which results in a third delay in diagnosis and treatment. This second study is called a CPAP titration. If the technicians fail to accurately score—or do not score at all—while titrating pressures, the study often results in Therapy Errors with unnecessarily high CPAP pressures.
The home therapy begins with the consumer obtaining a prescription from a physician for a sleep therapy machine. The referring physician will request an office visit to review the results and write the prescription—a fourth delay in diagnosis and treatment. The most common requested device is a fixed pressure machine, which is dated technology. This equipment is provided to the consumer by a durable medical equipment provider. The equipment can be delivered to the consumer's home by anyone or even mailed. Decisions by the equipment company regarding which machine to place in the consumer's home may lead to consumers receiving low quality sleep therapy machines and even different machines from the one requested in the physician's order. Once delivered, the majority of consumers receive no monitoring or follow-up, especially middle-aged consumers, for whom the healthcare system typically does not reimburse for nor encourage extra monitoring. After a rental period the equipment is owned by the consumer.
HITECH sleep therapy machines capture sleep therapy data in onboard memory systems. The machine can collect sleep therapy data on a digital memory storage device similar to those used for a digital camera. Unless the physician or the equipment company has a card reader to download the information to be reviewed, the data remains in the sleep therapy machine. If the information is downloaded for a report, the card is erased and the past data is lost to any future point of care provider. Thus, data collection remains quite limited.
Another alternative is to collect the sleep therapy data into a manufacturer database (e.g., EncoreAnywhere®, a web-based database provided by Royal Philips Electronics). Here, the consumer has no access to their own data, and full control over the database is vested in the equipment company. The database administrator at the equipment company may not even be a medical professional, but they access the database and may have the ability to grant access to others without the consumer's knowledge or authorization. If the consumer switches to another equipment company the past data typically remains with the previous company, and is lost to any future point-of-care provider. These current practices do not recognize the consumer's rights to protect the privacy/security of their own electronic data, and are not HIPAA HITECH compliant.
There still exists in the art, accordingly, a need for the collection of home sleep therapy data to improve overall scientific knowledge while concurrently acknowledging privacy and security concerns and affording consumers control over their own health data. The need in the art extends to systems and devices that provide for one or more or all of the following features: improved quality and efficiency through the elimination of unnecessary care; reduction of chronic health conditions through disease management; cost control for sleep disorders; information technology with centralized electronic medical records; secure storage of electronic personal health information; coordination of care to provide timely access or availability; and encouragement of consumer-driven healthcare.